MAUDE Adverse Event Report: CONMED CORPORATION ALLIGATOR GRASPER, STRAIGHT, 3.4MM X 130MM; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 11.1002

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned 11.1002 device found the device discolored with worn etching and the tip worn/damaged.The manufacturing documents from the device history record were not reviewed due to the device having been in the field for more than 12 months.The service history was reviewed and no prior data was found.(b)(4).Per the instructions for use, the user is advised the following: precautions: inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the use of the device to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect instrument after use to ensure it has not been damaged.Instrument is designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper technique for use.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 11.1002, had the bottom jaw break off the device.A good faith effort was performed to gain more information; however, no response has been received from the reporter to date.There was no report of injury to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ALLIGATOR GRASPER, STRAIGHT, 3.4MM X 130MM
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo, fl
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd.; largo, fl
• Manufacturer Contact: john berga ; 11311 concept blvd.; largo, fl ; 3995358
• MDR Report Key: 9775054
• MDR Text Key: 193005925
• Report Number: 1017294-2020-00086
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11.1002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1